Cleared Special

K102178 - EASY TOUCH

K102178 is an FDA 510(k) clearance for EASY TOUCH, manufactured by Mhc Medical Products. The device is a Class 2 General Hospital device with product code FMF cleared through the Special 510(k) pathway after a 30-day FDA review.

K102178 · Mhc Medical Products · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
30d
Days
Class 2
Risk

K102178 is an FDA 510(k) clearance for the EASY TOUCH. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Mhc Medical Products (Naples, US). The FDA issued a Cleared decision on September 2, 2010 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K102178

510(k) Number K102178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2010
Decision Date September 02, 2010
Days to Decision 30 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 129d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 634
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K102178.
INDISCAL DIGITAL MANOMETER
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K101359 · Inviro Medical Devices, Inc. · Aug 2010
HUMAPEN LUXURA HD
K100988 · Eli Lilly and Company · Aug 2010
MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX
K100665 · Needle Tech Products, Inc. · Jun 2010
K102178 · EASY TOUCH
Download PDF FDA Summary Mhc Medical Products